Abstract

UPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND LEDIPASVIR IN TABLET DOSAGE FORM

A simple, precise, specific and stability-indicating UPLC (Ultra Performance Liquid Chromatography) method was developed and validated for the simultaneous estimation of anti-viral drugs Simeprevir and Sofosbuvir in combined dosage form. The method was developed using SD C18 column (100 mm×2.1 mm, 1.8?m) with isocratic elution. 0.1% ortho phosphoric acid buffer and acetonitrile (60:40 v/v) were used as mobile phase with 0.2 ml/min flow rate at ambient temperature. The detection wavelength was fixed at 220 nm. The run time was within 2 min. The method was validated in terms of linearity, accuracy and reproducibility. Calibration plots were linear over the range of 37.5-225 ?g/ml for Simeprevir and 100-600 ?g/ml for Sofosbuvir. The Recovery was in the range of 98-102% with the relative standard deviation of less than 2% for both drugs. The mean recoveries were found to be 99.41% and 99.91% for Simeprevir and Sofosbuvir respectively. The relative standard deviation (RSD) was found to be < 2.0% for both drugs. The limit of detection and the limit of quantification for the Simeprevir were found to be 0.51 and 1.55 ?g/ml respectively and for Sofosbuvir 0.50 and 1.52 ?g/ml respectively. The proposed method was validated and successfully applied to the estimation of Simeprevir and Sofosbuvir in tablet dosage form.